Clinical Monitoring Oversight Manager (Security)
About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.
A Brief Overview
Sponsor oversight of monitoring activities to ensure the effective and efficient delivery of the operational aspects in accordance with applicable regulations, requirements, and procedures.
What you will do
- Clinical Projects Oversight:
- Oversee site and monitoring activities across clinical studies to maintain quality standards
- Build and maintain site relationships across clinical studies
- Oversee external CRA training to ensure compliance is maintained
- Review percentage of trip reports, metrics, protocol deviations and follow-up items, to evaluate compliance and ensure corrective and preventative actions are implemented
- Identify monitoring trends across clinical studies and communicate them within trial team and Clinical Operations Team
- Interact with Trial Team members and CRO/vendor personnel, as needed
- Clinical Project Quality Management:
- Oversee site inspection readiness, including health of Trial Master File (TMF)
- Support site and Sponsor audits and inspections
- Participate in investigator meetings and trainings to ensure quality
- Perform co-visits with external CRAs for site initiation visits and selected monitoring visits
- Conduct additional checks as outcome of internal medical monitoring/clinical checks, as needed
- Vendor Qualification and Oversight:
- Participate in KPI determination for CROs and vendors
- Attend governance meetings with vendors, when applicable
- Ensure quality of vendor´s monitoring systems, tools and templates including vendor selection processes
- Oversee monitoring visit scheduling and monitoring performance metrics via spot checks
- Liaise with CPMs to ensure that vendor proposals for monitoring tasks are adequate.
- Process Development:
- Develop and maintain monitoring SOPs, templates, and tools, including risk-based and centralized monitoring
- Set-up and maintain a QTL database inclusive tracking.
- Reporting:
- Regular reporting to senior management of the Clinical Projects Group as necessary.
- Change Management:
- Support the implementation of new processes across R&D and engage in internal team trainings as needed.
- Other duties as assigned:
- Travel up to 50% Required
Minimum Requirements:
- Bachelor's degree in life sciences or medical health or other professional qualifications equivalent to university degree
- 6+ years' Experience in different medical indications, study designs and phases of clinical development of medicinal products or medical devices
- 5+ years' experience as a clinical research associate
- 2+ years' experience as a Lead CRA, Clinical Trial Lead or equivalent
- Experience in clinical study processes
- Previous experiences in the leadership of interdisciplinary and international teams
Technical & Functional Skills:
- Basic statistical understanding
- Fluent business English
- Experience with CTMS, IVRS and EDC system
- Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reports, and presentations
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Research and Development
